CClinicalTrials.gg
CompletedNCT07542535Updated Apr 21, 2026

Music Effects on Dementia

An interventional study of Music Therapy in Dementia, Music Therapy and Caregiver Burden of People With Dementia, sponsored by Instituto Nacional de Geriatria, Mexico. Completed at 1 site in Mexico. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Instituto Nacional de Geriatria, Mexico · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Nov 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

Older adults constitute a population whose age-related physiological and cognitive changes predispose them to conditions that are less likely to occur in younger individuals. Dementia encompasses a group of health conditions that primarily affect this age group. These disorders commonly impair mental functions-particularly memory-but they also manifest through behavioral symptoms, such as irritability, and exert a significant impact not only on the affected individual but also on their immediate environment.

In this study, the investigators will implement a structured musical improvisation intervention led by four professional concert musicians. This approach, which has demonstrated effectiveness in other populations, aims to evaluate its effects on the mental and physical health of older adults living with dementia. Additionally, the intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia.

Previous studies have reported the effectiveness of such interventions, noting improvements in memory, behavioral symptoms, and even overall physical well-being. To date, no studies of this nature have been conducted in our country, making this the first to pursue an extensive exploration of outcomes-not only those traditionally assessed in similar trials, but also a broader evaluation of various dimensions of health in older adults undergoing the intervention. Additionally, caregivers may also benefit from actively participating in these sessions, which are designed to include them from the very beginning. Beyond generating data on the potential effects across different bodily and cognitive functions-knowledge that may become a leading reference in this field-this intervention holds the potential to be scaled up, thereby benefiting a larger population and ultimately enhancing the care provided to older adults living with dementia.

Read the detailed description

Older adults are a group of people whose age makes them prone to developing conditions they would not have if they were younger. Dementias are a group of health conditions that commonly occur in older adults. They are a group of conditions that affect, among other mental functions, memory; but they often present other behavioral manifestations (such as irritability) and impact not only the person suffering from them, but also those around them. In this study, the investigators will use musical improvisation led by four concert musicians through a structured intervention which has proven effective in other populations-to understand the effects on the mental and physical health of older adults with dementia; the investigators will also assess caregivers to determine whether this intervention has an impact beyond the person with dementia. There is evidence regarding the effectiveness of these treatments, with improvements observed in memory, behavioral symptoms, and even the person's overall physical condition. On the other hand, it will be the caregivers who may also benefit by actively participating in these sessions, which involve them from the very beginning.

02

Conditions studied

  • Dementia
  • Music Therapy
  • Caregiver Burden of People With Dementia
  • Neuropsychiatric Symptom
  • Frailty
  • Aged (80 or More)
  • Non-Pharmacological Interventions

Keywords

  • Aged
  • Dementia
  • Alzheimer´s disease
  • Vascular dementia
  • Non pharmacological therapy
  • Music Therapy
  • Caregiver burden
  • Frailty
03

In context

Dementia

2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.

This study's enrollment of 7 is below the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

This is the only study on the registry with Instituto Nacional de Geriatria, Mexico as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Older adults aged 60 years or older
  • Positive screening result for Alzheimer´s disease, vascular dementia, or mixed dementia
  • Prior diagnosis of dementia in a mild or moderate stage
  • Individuals capable of performing minimal physical activity
  • Complete vaccination schedule for COVID-19 and influenza

Exclusion criteria

Exclusion criteria:

  • Individuals currently participating in a similar intervention or received similar intervention within the past 6 months
  • Undergoing continous treatment for another health condition
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Music therapy in caregiver burden of dementia patients: A quasi-experimental study

    The intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia. Additionally, two other outcomes will be assessed as secondary goals: frailty and neuropsychiatric symptoms.

    Other: Music Therapy

Interventions

  • OtherMusic Therapy

    Each session lasts three hours and includes preparation and rehearsal, an introductory improvisation with musical instruments, improvisation by patients and their caregivers with small percussion instruments, and finally, an artistic reflection involving musicians, caregivers, and patients

06

What researchers measure

Primary outcomes

  1. Neuropsychiatric symptoms

    This outcome was assessed with the Neuropsychiatric Inventory Questionnaire, has a score that ranges from 0 to 12, with the lowest score meaning no neuropsychiatric symptoms and 12 the highest neuropsychiatric symptom burden possible. Additionally, if the symptom is present, a severity scale is applied for the symptom, that ranges from 0 to 36.

    Time frame: 8 weeks

Secondary outcomes

  1. Caregiver burden

    The caregiver burden was assessed with two instruments. The first one is the one linked to the NPI-Q, in which the caregiver is asked about the stress a particular symptom raises. This tool goes from a score 0 to 60, with zero the lowest stress possible and 60 the highest stress possible. Additionally, caregiver burden was also measured with the Scale of Caregiver Burden from Zarit \& Zarit, that goes from 22 to 110; 22 is the lowest score and burden possible while 110 the highest.

    Time frame: 8 weeks

  2. Frailty

    The Short Physical Performance Battery, this test explores three different tasks, gait speed, balance and endurance. Each one of the sub-tests has a maximum score of 4 and zero as the lowest possible. By adding up each subtest, the complete battery score ranges from 0 to 12; a cut-off point for frailty of 10 was used.

    Time frame: 8 weeks

  3. Depression

    This was measured with the Geriatríc Depression Scale of 15 items from Yesavage. The lowest score possible reflects a low burden of depression, while the highest could reflect clinical depression.

    Time frame: 8 weeks

07

Study locations

1 site
  • Instituto Nacional de Geriatria
    Mexico City, Mexico City 10200, Mexico
08

References and documents

Publications

  • Salihu D, Chutiyami M, Bello UM, Sulaiman SK, Dawa KK, Hepworth A, Adeleye KK, Alruwaili MM. A meta-review of systematic reviews on the effectiveness of music therapy on depression, stress, anxiety and cognitive function in adult's with dementia or cognitive impairment. Geriatr Nurs. 2024 Nov-Dec;60:348-360. doi: 10.1016/j.gerinurse.2024.09.014. Epub 2024 Oct 9. PubMed 39388962 ↗
  • Ting B, Chen DT, Hsu WT, Tsai CL, Malau IA, Lee SL, Jingling L. Multifaceted Music Therapy for Depression in Dementia: A Network Meta-Analysis of Randomized Controlled Trials. Eur J Investig Health Psychol Educ. 2024 Feb 11;14(2):351-367. doi: 10.3390/ejihpe14020024. PubMed 38391491 ↗
  • Ting B, Su CH, Chen DT, Hsu WT, Tsai CL, Lin PY, Jingling L. The Sound of Memory: Investigating Music Therapy's Cognitive Benefits in Patients with Dementia-A Network Meta-Analysis of Randomized Controlled Trials. J Pers Med. 2024 May 8;14(5):497. doi: 10.3390/jpm14050497. PubMed 38793079 ↗
  • Wong ARK, Ng LTE, Lee MH, Yeow JLH, Lim YJ, Yap KH. The effectiveness of group music reminiscence therapy for people thriving with dementia: A systematic review of randomized controlled trials. Aging Med (Milton). 2024 Aug 17;7(4):528-534. doi: 10.1002/agm2.12344. eCollection 2024 Aug. PubMed 39234199 ↗
  • Xu H, Li A, Apuke OD. The impact of group music therapy in ameliorating the depression among patients with dementia in care homes: A randomized control trial. Geriatr Nurs. 2024 Mar-Apr;56:304-311. doi: 10.1016/j.gerinurse.2024.02.021. Epub 2024 Feb 27. PubMed 38417183 ↗
  • Yuan SH, Silverman MJ, Cevasco-Trotter AM, Wang SG. Ten Reasons Why Neurologists Should Refer Patients With Alzheimer Dementia to Music Therapy. Neurol Clin Pract. 2024 Dec;14(6):e200357. doi: 10.1212/CPJ.0000000000200357. Epub 2024 Aug 16. PubMed 39185103 ↗
  • Borda MG, Landi F, Cederholm T, Venegas-Sanabria LC, Duque G, Wakabayashi H, Barreto GE, Rodriguez-Sanchez I, Canevelli M, Cano-Gutierrez C, Perez-Zepeda MU, Wallace L, Rockwood K, Salas-Carrillo M, Gjestsen M, Testad I, Ballard C, Aarsland D; IPEFUND. Assessment and management of frailty in individuals living with dementia: expert recommendations for clinical practice. Lancet Healthy Longev. 2025 Jan;6(1):100666. doi: 10.1016/j.lanhl.2024.100666. Epub 2024 Dec 27. PubMed 39736268 ↗
  • Mei Z, Zhang Y, Zhao W, Lam C, Luo S, Wang S, Luo S. Music-based interventions for anxiety and depression in older adults with dementia: A systematic review of randomized controlled trials. Complement Ther Clin Pract. 2025 May;59:101951. doi: 10.1016/j.ctcp.2025.101951. Epub 2025 Jan 13. PubMed 39826392 ↗

Study documents

  • Study protocol · Sep 24, 2025
  • Statistical analysis plan · Sep 24, 2025
  • Informed consent form · Sep 24, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Once the main analysis is finished, the data will be shared upon request to the main researcher.

Supporting information: Study protocol, Sap, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07542535
Lead sponsor
Instituto Nacional de Geriatria, Mexico
Collaborators
Universidad La Salle, Mexico, National Polytechnic Institute, Mexico
Responsible party
Mario Ulises Perez Zepeda (Clinical Researcher, Instituto Nacional de Geriatria, Mexico) — Principal investigator
First posted
Apr 21, 2026
Start date
Nov 10, 2025
Primary completion
Dec 20, 2025
Completion
Dec 20, 2025
Last update
Apr 21, 2026

Study contacts

Mario U Perez
principal investigator · Instituto Nacional de Geriatria, Mexico

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion